Cover Story: Safety Considerations in Drug Product Changes

September 2008 - Vol. 5 No. 9

Therefore we look for a product that works best with our systems or one that requires minimal manipulation to adopt, particularly if it is a temporary change in response to a drug shortage. While cost is certainly a consideration in any drug change evaluation, there are many additionally important factors to evaluate.

Depending on the medication, a new product must be successfully incorporated within a multitude of systems. In our case, we need to consider how it will work with the carousel medication storage/inventory system (Workflow RX), the SafetyPak bar code packaging system, and the Omnicell automated dispensing cabinets. In some situations, we also need to consider the impact a new product will have on the TPN Compounder (Baxa ExactaMix),anesthesia medication trays and emergency drug supplies in the drug boxes and crash carts. Additionally, with any drug product change we evaluate whether updates are needed in our information systems, including the Cerner PowerChart CPOE and Cerner PharmNet PIS.

System Assessment

Evaluating the effect a new product will have on the multiple systems involved in drug storage, packaging, ordering, distribution,and administration, is essential. In order to manage this complex process, we have developed the Drug Product Change Evaluation Form (see page 20). This form serves as a checklist to ensure that the process of incorporating a new drug product is handled properly. Once a system is noted on the form as being impacted by a new product, responsibility is assigned to a staff member to follow-up on the identified action plans.

Storage and Packaging Review

From a safety standpoint, drug storage is a major issue. As the number of look-alike/sound-alike products is continually increasing, we need to be proactive and identify and address potential problems in this area.With foresight, products can be positioned in the carousel to offset these problems. Additionally, to avoid filling errors, different strengths of the same product are separated within the carousel.

When reviewing potential replacement products, the primary goal is to use products available in unit dose to avoid repackaging or compounding. When there is a choice between two or more products, we compare the quality of the packaging and labeling for clarity. For example, many injectable products express concentration and total vial quantity in different ways (mg versus mL volume). We want to avoid products that could introduce confusion. For products that need to be repackaged into unit dose and labeled in-house, we want to be sure our labels are complete and correct and whether tall-man lettering is appropriate. In addition, the product concentration is reviewed to make sure it is the same as the preferred product, and hence correlates with our information systems to avoid compounding/dose errors.

Information Systems

In the CPOE system, we strive to include as many medication order sentences as possible to simplify the ordering process for the prescriber. Order sentence details can include all or some of the following;the drug, dosage form, dose, route and schedule. Special instructions can also be included in the order sentences (e.g. do not crush) to provide important information. For our standardized infusions/drips, all of the choices are built-in so the prescriber can pick the drug and the recommended dosing. For both the medication order sentences and the standard infusions, the prescriber has the option to make any necessary patient-specific changes to the order. To provide extra information at the time of ordering we can utilize clinical decision support alerts for more long term information (i.e., IVIG usage restrictions during a shortage) or more commonly, pop-up alerts (ie.,highlighting dosage information or look-alike/sound-alike warnings). While infrequent, injectable medication concentration changes are especially challenging to provide appropriate information to both pharmacy and nursing staffs.To accommodate concentration changes, the pharmacy dispensing system needs to be updated to generate a correct label. Pharmacists need to know the preparation and dispensing needs for the new concentration. Pop-ups work well for pharmacists through the dispensing system but for nurses, the information is best obtained while retrieving medications from the ADM where we may post signs or place information in a medication bin. {mospagebreak title=Page 2}

ADM Storage Issues

In reviewing the effect a new product will have on ADM storage,the most common issue is size, as that can affect par levels. If a new product is larger, even in unit-dose packaging, the quantity of available drug in that bin could be less. Tablet package sizes can vary amongst manufacturers, as can the size of bulk medications of ointments, creams, etc. It is necessary to ascertain the impact of product size and make a corresponding change to the par level if needed, especially for items with low par levels, to avoid problems with medication availability and more frequent stock-outs. Just as the placement of any possible look-alike/sound-alike products in the carousel is reviewed, we are also vigilant in reviewing product placement in each ADM and all pharmacy satellite storage locations to ensure these products are not stored next to each other or, to implement safeguards if necessary. ADM storage issues for new product additions may require database changes to avoid unsafe storage and set accurate par levels, which will head off any hassles for the staff.

Drug Product Change Committee

Because of the complexity of the drug storage, ordering,distribution and administration systems, it is imperative that potential problems are addressed proactively to ensure safety and efficiency, allowing the staff to focus on other important aspects of their job. The drug product change committee charged with this responsibility is made up of individuals who each own a unique part of the evaluation process. My role is to identify any potential medication safety issues. Another person takes ownership of the financial and medication use aspects. An operational person is responsible for evaluating the potential impact of the product on the system and how changes could affect staff workflow. The manager of the purchasing area coordinates the activities identified by the group via the drug product change form and works with the purchasing agent to obtain the desired product. The timing of incorporating the new product into the system is critical, as well as returning the original product back into operations, so communication is very important.

With this group approach to product review, we attempt to identify and address all potential problems that could arise with the implementation of a new product by utilizing the Drug Product Change Evaluation form to track identified problems, responsibilities, and actions. Additionally,when time permits, we solicit the input of the Medication System Review Committee (MSRC) which includes pharmacists, nurses, Risk/Safety, IS, and a physician, in order to include their broader insights into the decision making process.

By capturing all of the elements that could be affected by a product change on the Drug Product Change form, the group is able to evaluate the appropriateness of a product change beyond simply comparing pricing. For example, if a product we currently receive in unit dose is available at a lower price in bulk, we need to evaluate the cost of repackaging it in the pharmacy.However, in addition to measuring cost differences and staff workload, we need to consider that anytime pharmacy is manipulating a product, we are introducing the potential for an error to occur. Another important factor for a drug product change is determining the anticipated length of time of the shortage.If the purchasing agent informs the group in advance that a medication is becoming difficult to obtain, the purchasing agent may be requested to obtain as much supply as possible and update the group at a specified stock level.During a review we also consider whether the product change is permanent or temporary. Generally, for temporary situations related to drug shortages, we prefer to stock the regular product again once the shortage is over.Additionally, when we review a product that works well in our system, the original product may be preferred but we can designate selected alternative products previously reviewed as ‘Switch between products OK’, to identify products that the purchasing agent does not have to bring to the groups’ attention during future product shortages.

Staff Education

When a product change is made, we need to determine whether staff education is warranted. Often, a new product is so similar to the one it is replacing that no specific education is necessary. For changes that warrant specific communication, we can use the organization-wide list serve to make e-mail announcements. E-mail is useful particularly when a change is ongoing,such as with recent heparin supply issues, where the available product was changing quickly. The downside to e-mail is that front-line staff is not always able to keep up with their e-mail. It is important to request that nurse managers disseminate any information they receive via e-mail to their staff,since not all nursing staff members are included on an accessible listserve or able to read e-mail on a regular basis. Another option is to post information on the ADMs to provide direct communication to the nurses. In some cases we have put notes inside the ADM medication bins. Nursing meetings are another opportunity for communication, when there is time to plan ahead. We also rely on the pharmacists working on the nursing units and in the satellite pharmacy areas to answer any questions as they come up. For a significant long-term change, clinical pharmacists and/ort heir students may provide an in-service to a patient care area.

Another charge for the group is determining whether any clinical information needs to be disseminated, and if so, the content and audience for the information. A medication-use guideline or protocol may be needed for prioritizing medication use when supply is low or unavailable, for example with IVIG, albumin, or antibiotics.


Drug shortages are a common occurrence and require the use of alternate products. A poorly executed change can increase the risk for error and decrease efficiency. Hence, a systematic approach is required, wherein the key players are able to address all of the relevant issues. If the job is done correctly during the drug product change review process, the rest of the staff is able to do their job more efficiently and with fewer hassles. The value of this to both patient safety and staff satisfaction cannot be overstated. ■

LarsonConnieConnie Larson, PharmD, earned a doctor of pharmacy degree from the University of Illinois at Chicago, College of Pharmacy and currently serves as medication safety officer at the University of Illinois Medical Center at Chicago.

Click here to download the University of Illinois Medical Center at Chicago's Drug Product Change Form


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